510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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IYHClass II

Generator, Dermatological (Grenz Ray), Therapeutic X-Ray

21 CFR 892.5900 / Radiology
FDA source (opens on fda.gov)

IYH is the FDA product code for Generator, Dermatological (Grenz Ray), Therapeutic X-Ray, a class II device type, regulated under 21 CFR 892.5900. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
IYH
Device name
Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
1

Clearances, product code IYH

By decision year
1 clearance under product code IYH with a decision year between 1987 and 1987, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IYH by decision year
YearClearances
19871

Applicants with the most clearances

Product code IYH
Applicants holding the most 510(k) clearances under product code IYH
ApplicantClearances
X-Cel X-Ray Corp1

Companies listing this code with FDA

Companies whose registered establishments list this code